BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP UNISET VENA CAVA FILTER SET

    MDR report key: 2850732 · Received November 20, 2012

    Report

    Report Number
    1820334-2012-00518
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    April 9, 2007
    Report Date
    July 21, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA BASED ON NEW INFORMATION RECEIVED: UPDATED ATTORNEY NAME, SERIOUS INJURY TO MALFUNCTION. UNKNOWN IF THE FOLLOWING PATIENT AND DEVICE CODES ARE LISTED IN THE IFU. PRODUCT INFORMATION NOT PROVIDED. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THIS PROBLEM REPORT IS BASED SOLELY ON INFORMATION FROM THE PT. NO IMAGES, DEVICE, OR MEDICAL RECORDS HAVE BEEN AVAILABLE TO ASSIST THE INVESTIGATION. BASED ON DESCRIPTION A LOT OF QUESTIONS REMAIN UNKNOWN, HOWEVER, THERE ARE NO INDICATIONS THAT THE IMPLANTED FILTER WILL NOT FUNCTION AS INTENDED, DESPITE THE PERFORATION, AND THEREFORE, IT IS NOT KNOWN WHY COUMADIN TREATMENT HAS BEEN INDICATED. NO CT IMAGES WERE PROVIDED TO CONFIRM WHETHER THE FILTER PERFORATED THE IVC OR IS IN A TENTING SITUATION. IT IS UNKNOWN WHY THE FILTER CANNOT BE REMOVED BY MINIMAL INVASIVE PROCEDURE. HOWEVER, FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. DESPITE PERFORATION THE MAJORITY END UP IN SUCCESSFUL FILTER RETRIEVAL. ACCORDING TO ARTICLE "AN ADDITIONAL ISSUE ARISES WHEN PHYSICIANS DENY PTS THE OPTION OF FILTER RETRIEVAL BECAUSE OF CONCERNS FOR COMPLICATIONS WHEN STRUTS ARE SEEN EXTERNAL TO THE IVC WALL. THIS STUDY SHOWED NO MAJOR COMPLICATIONS IN RETRIEVING FILTERS CONTAINING STRUTS OUTSIDE THE IVC WALL." ALSO STATES THAT "IN PSEUDOPENETRATION, THE FILTER LEGS CAUSE "TENTING: OF THE VENA CAVA OR BECOME BURIED IN MURAL THROMBUS, WHEREAS IN TRUE PENETRATION, THERE IS ACTUAL EXTENSION OF THE STRUTS BEYOND THE WALL. WE SUGGEST RETRIEVAL OF PENETRATING OPTIONAL FILTERS TO PREVENT LONG-TERM COMPLICATIONS". ARTICLE STATES THAT "THERE ARE NO PUBLISHED GUIDELINES FOR SURGICAL OR ENDOVASCULAR REMOVAL OF PERFORATED IVC FILTERS. REMOVAL IS CONSIDERED BASED ON THE SEVERITY OF SYMPTOMS AND PERCEIVED LONG TERM ADVERSE OUTCOMES". RELEVANT ARTICLES: OH JC, TREROTOLA SO, DAGLI M, ET AL. REMOVAL OF RETRIEVABLE INFERIOR VENA CAVA FILTERS WITH COMPUTED TOMOGRAPHY FINDINGS INDICATING TENTING OR PENETRATION OF THE INFERIOR VENA CAVA WALL. J VASC INTERV RADIOL 2011;22:70-4. M. ARABI, MD, FRCR, J. M. WILLATT, MBCHB, J. J. SHIELDS, MD, K J. CHO, MD, AND W. B. CWIKIEL, MD, PHD; RETRIEVABILITY OF OPTIONAL INFERIOR VENA CAVA FILTERS WITH CAUDAL MIGRATION AND CAVAL PENETRATION: REPORT OF THREE CASES, J VASC INTERV RADIOL 2010; 21:923-926. T. D. TOWNSEND, S. RATHBUN, A. GAUTAM, AND T. WHITSETT, IMAGES IN VASCULAR MEDICINE. PERSISTENT ABDOMINAL PAIN FROM A PERFORATED INFERIOR VENA CAVA FILTER 86, VASC MED., 12 (20007) 33-34. ALICIA LABORDA, DVM, PHD ET AL: LAPAROSCOPIC DEMONSTRATION OF VENA CAVA WALL PENETRATION BY INFERIOR VENA CAVA FILTERS IN AN OVINE MODEL. IN REVIEWING THE INSTRUCTIONS FOR USE (IFU) UNDER THE SECTION OF POTENTIAL ADVERSE EVENTS, THE FOLLOWING IS MENTIONED: VENA CAVA PERFORATION. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE LOT NUMBER IS UNKNOWN. BASED ON THE CURRENTLY PROVIDED INFORMATION, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE LED TO THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. THE INCLUSION OF THIS EVENT INTO QUALITY ENGINEERING RISK ANALYSIS WOULD NOT CHANGE THE CONCLUSION THAT NO RISK MITIGATING ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING 'MIGRATION, TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED '. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. MANIPULATION IN THE AREA OF THE FILTER IMPLANT MAY CAUSE MIGRATION OR CONTRIBUTE TO CHANGES IN THE FILTER CONFIGURATION AND PLACEMENT. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Description of Event or Problem · 1

    BECAUSE OF A SEVERE CASE OF PULMONARY EMBOLI AND DEEP VEIN THROMBOSIS, THE HEMATOLOGIST SUGGESTED A TEMPORARY INFERIOR VENA CAVA FILTER (IVC FILTER). AFTER AN OUTPATIENT SURGERY TO REMOVE THE FILTER, THE PT WAS TOLD THAT IT COULD NOT BE REMOVED BECAUSE ONE OF THE PRONGS HAD PUNCTURED A MAJOR VESSEL. REMOVAL OF THE IVC WOULD RESULT IN MAJOR VASCULAR SURGERY. THE DEVICE WAS LEFT IN THE PT.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 27JUL2016 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE JUGULAR VEIN DUE TO RECURRENT DVT AND PE. PLAINTIFF IS ALLEGING MIGRATION, TILT, VENA CAVA PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED, REQUIRING COUMADIN INDEFINITELY, SUFFERED HEMORRHAGIC MENORRHEA REQUIRING HYSTERECTOMY. PATIENT ALLEGES ATTEMPTED RETRIEVAL ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention